Scope of Work

Design and construct Stanford’s first academic GMP lab space to produce individualized therapies for phases one and two clinical trials. These cell products will be delivered to patients enrolled in the trial. The lab and the processes within it must comply with FDA regulations for Current Good Manufacturing Practice (cGMP) facility. cGMP guidelines required facilities to maintain a high level of sterility, a strict protocol for chain of custody, and safeguards to ensure consistent performance.